…medical problems arising during participation in the trial, reasonable access to medical care, and attention to protocol violations that can expose study subject to unreasonable risks. By Noelle C. Sitthikul…

…Congress might also hold hearings on the health risks associated with EAADM, and Representatives Dan Burton (R-IN) and Diane Watson (D-CA) reportedly plan to reintroduce legislation that would phase-out dental…

…Intervention, CTI allegedly implemented a plan to convince physicians and Medicare carriers that various off-label uses of TRISENOX were medically accepted and eligible for Medicare reimbursement.  Many oncologists rely on…

The Deficit Reduction Act of 2005 (“DRA”) provided that any entity that receives or makes annual payments under a Medicaid State plan of at least $5,000,000 must, as a condition…

…the other that although the “Court well understands and respects historical sentencing practices for responsible corporate officers under the Park doctrine . . . This case stands alone.”  This scenario…

…the fiscal year-over-fiscal year “potential pay-for-delay” deal numbers, you compare the “potential pay-for-delay” deals as a percentage of the overall final settlement agreements for each fiscal year, then there is…

…all clinical and non-clinical testing planned for a proposed breakthrough device. Review of a DDP is requested through a pre-submission. The DDP is an optional element of the breakthrough device…

…a normal Pre-Submission, three-to-four questions could relate to a clinical study plan alone without addressing other important questions such as regulatory strategy. The guidance does not state what, if anything,…

…of FCA conspiracy counts, explaining that, while alleged conduct involving off-label promotion to increase the number of drug prescriptions “may be condemnable” (if true), such an alleged plan “does not…

…relator alleged the nursing facilities violated Medicaid regulations, which rendered fraudulent its claims to the Medicaid program. The alleged non-compliances involved a failure to maintain a comprehensive care plan and…

On December 5, 2017, FDA issued a final guidance: Technical Considerations for Additive Manufactured Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Additive Manufacturing (AM) is “a…

…report critical about the agency’s oversight of certain food recalls. In response to that report, Commissioner Gottlieb issued a statement indicating that the agency intended to take “additional policy steps……

…to have a UDI on its label and packages unless an exception or alternative applies. 21 C.F.R. § 801.20. There are special labeling requirements that apply to stand-alone software regulated…

…Orphan drug designations and approvals (which include not only approvals of NDAs for new molecular entities and BLAs for original biological products, but also applications approved for new orphan uses…

…first ANDA applicant for Mesalamine Delayed-Release Tablets USP, 1.2 g, to submit a substantially complete ANDA with a paragraph IV certification. Therefore, with this approval, Zydus may be eligible for…